Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – May 2026
Key EMA News Updates:
- EMA marks European Immunization Week 2026
To support informed decision-making on vaccination, the EMA highlighted its efforts to provide accessible, evidence-based information and launched a new webpage dedicated to RSV vaccines. Click here for more details: EMA – EMA marks European Immunization Week 2026 - New advisory group on vaccine confidence launched
The EMA has established a new international advisory group of 20 experts to support initiatives aimed at strengthening public trust in vaccines and enhancing science communication and outreach. Click here for more details: EMA launches new advisory group on vaccine confidence | European Medicines Agency (EMA) - Pilot launched for ‘breakthrough’ medical devices
A new pilot programme will test an innovative regulatory pathway intended to facilitate patient access to highly innovative medical devices while maintaining high safety and performance standards. Click here for more details: New pilot to support development of ‘breakthrough’ medical devices | European Medicines Agency (EMA) - Inside EMA podcast Episode 6 – supporting innovation
The latest podcast episode explores how the EMA supports medicine developers throughout the lifecycle of innovation, from early concepts to patient access. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA) - First veterinary RNA-based vaccine recommended for approval
The EMA has recommended authorisation of the first veterinary vaccine using RNA technology in the EU, intended to protect cats against several highly infectious diseases. Click here for more details: EMA recommends authorisation of first veterinary vaccine using RNA technology | European Medicines Agency (EMA)
Medicines:
- Cenrifki (Tolebrutinib)
New medicine recommended for approval: on 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for Cenrifki, intended for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the previous two years. Click here for more details: Cenrifki | European Medicines Agency (EMA) - Itvisma (Onasemnogene abeparvovec)
New medicines recommended for approval: on 23 April 2026, the CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Itvisma, intended for the treatment of spinal muscular atrophy (SMA) in children from two years of age with bi-allelic mutations in the SMN1 gene. Click here for more details: Itvisma | European Medicines Agency (EMA) - Aquipta (Atogepant)
New indication: on 23 April 2026, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for Aquipta for the acute treatment of migraine with or without aura in adults. Aquipta is already approved for the prophylaxis of migraine in adults experiencing at least four migraine days per month. Click here for more details: Aquipta – opinion on variation to marketing authorisation | European Medicines Agency (EMA)
